Phase 4
Completed N=244
Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily
Source: ClinicalTrials.gov NCT00634842 ↗Enrolled (actual)
244
Serious AEs
3.7%
Results posted
Dec 2009
Primary outcomePrimary: Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% — 64.3; 54.5 percentage of participants — p=0.0411
Summary
This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% |
64.3; 54.5 | 0.0411 sig |
| SECONDARY Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% |
41.1; 26.8 | 0.0064 sig |
| SECONDARY Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline |
-1.229; -0.958 | 0.0019 sig |
| SECONDARY Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) |
333; 227; 1; 0; 225; 136 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- 1-3 oral treatments
- Insulin naive
- BMI (Body Mass Index) less than or equal to 45
Exclusion Criteria
- Pregnancy
- Retinopathy
- Cardiac disease
- Uncontrolled hypertension
- Recurrent hypoglycaemia
Data sourced from ClinicalTrials.gov (NCT00634842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.